K223323 is an FDA 510(k) clearance for the Blood Collection Needle (with/without Needle Holder). This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing City, CN). The FDA issued a Cleared decision on March 24, 2023, 144 days after receiving the submission on October 31, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K223323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2022 |
| Decision Date | March 24, 2023 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |